HypertensionHypertensionNCT06845436
Effects of Combined High Intensity Interval Training and Resistance Training
A study testing Exercise and routine physical activity in people with Hypertension, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
Background: Hypertension has long been considered as a major risk factor for cardiovascular disease representing a high public health concern. Objectives: the purpose of this study is to evaluate the effects of combined HIIT and resistance training on body composition, blood pressure, and cardiorespiratory fitness in… Read more about this study
- Who is it for?
- Ages 40 to 60 years, men only
- Conditions the study is for
- Hypertension
- What is being tested?
- Exercise and routine physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Apr 2025to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- men aged between 40 and 60 years old,
- have been diagnosed with clinical stage 1 or 2 hypertension,
- being obese with body mass index more than 30 kg/m2
- physically inactive
Who cannot join
- musculoskeletal problems that may limit their ability to participate in resistance or HIIT programs
- diabetes mellitus
- a history of respiratory or chronic heart disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Prince Sattam bin Abdulaziz University
Riyadh, Alkharj, 16278
Ahmed Sayed Ahmed, +966564347031, a.aseil@psau.edu.sa
About this study
Official title: Effects of Combined High Intensity Interval Training and Resistance Training on Body Composition, Blood Pressure, and Cardiorespiratory Fitness in Obese Hypertensive Men
Background: Hypertension has long been considered as a major risk factor for cardiovascular disease representing a high public health concern.
Objectives: the purpose of this study is to evaluate the effects of combined HIIT and resistance training on body composition, blood pressure, and cardiorespiratory fitness in obese hypertensive men.
Read more
Methods: This study will make use of sixty obese hypertensive men aged 40 to 60 years. All participants meeting the eligibility criteria will be assigned to one of three groups; combined HIIT and resistance group, HIIT only group or control group. Combined exercise group subjects will undergo weekly three sessions of both HIIT and resistance training for sixteen weeks. The HIIT session will involve four four-minute high-intensity intervals with an intensity of at 80-95% of the HRmax interspersed with two-minute active recovery intervals with intensity of 40% to 60% of the HRmax. The resistance training session will be composed of eight exercises perform 3 sets of 8-12 repetitions with an intensity of 80% of the subject's estimated 1-RM. The HIIT only group perform 12 weeks of HIIT only. The control group subjects will be instructed not to change their usual daily physical activities routine and instructed to abstain from practicing any exercise regimens during the 12-week study period. Body composition measures, blood pressure and VO2peak will be assessed at baseline and at the end of the study period.
Results: All the outcome variables will be assessed at baseline and 12 weeks following the treatment period.
- Conditions
- Hypertension
- Being tested
- Exercise, routine physical activity
- Keywords
- hypertension., obesity, High Intensity Interval Training, resistance training, blood pressure
- Medical subject headings
- Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Combined exercise group subjects will undergo weekly three sessions of both HIIT and resistance training for sixteen weeks. The HIIT session will involve four four-minute high-intensity intervals with an intensity of at 80-95% of the HRmax interspersed with two-minute active recovery intervals with intensity of 40% to 60% of the HRmax.
routine physical activityOther
The control group subjects will be instructed not to change their usual daily physical activities routine and instructed to abstain from practicing any exercise regimens during the 12-week study period.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Combined exercise group subjects will undergo weekly three sessions of both HIIT and resistance training for sixteen weeks. The HIIT session will involve four four-minute high-intensity intervals with an intensity of at 80-95% of the HRmax interspersed with two-minute active recovery intervals with intensity of 40% to 60% of the HRmax. The resistance training session will be composed of eight exercises perform 3 sets of 8-12 repetitions with an intensity of 80% of the subject's estimated 1-RM. The HIIT only group perform 12 weeks of HIIT only. Receives: Behavioral: Exercise |
| control group | Other | The control group subjects will be instructed not to change their usual daily physical activities routine and instructed to abstain from practicing any exercise regimens during the 12-week study period. Receives: Other: routine physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure in mmhg
Measured: 12 weeks
peak oxygen consumption in ml/kg/min
Measured: 12 weeks
body weight in Kg
Measured: 12 weeks
body mass index in kg/m2
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Apr 2025
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince Sattam Bin Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Saied Mohammad, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845436
- Sponsor's protocol ID
- SCBR-430/2025
- Acronym
- Hypertension
- Status last verified
- Jun 2025
- First submitted
- 20 Feb 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined High Intensity Interval Training and Resistance Training on Body Composition, Blood Pressure, and Cardiorespiratory Fitness in Obese Hypertensive Men
- ClinicalTrials.gov ID
- NCT06845436
- Acronym / sponsor ID
- Hypertension / SCBR-430/2025
- Conditions
- Hypertension
- Keywords
- hypertension., obesity, High Intensity Interval Training, resistance training, blood pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Prince Sattam Bin Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Hypertension has long been considered as a major risk factor for cardiovascular disease representing a high public health concern.
Objectives: the purpose of this study is to evaluate the effects of combined HIIT and resistance training on body composition, blood pressure, and cardiorespiratory fitness in obese hypertensive men.
Methods: This study will make use of sixty obese hypertensive men aged 40 to 60 years. All participants meeting the eligibility criteria will be assigned to one of three groups; combined HIIT and resistance group, HIIT only group or control group. Combined exercise group subjects will undergo weekly three sessions of both HIIT and resistance training for sixteen weeks. The HIIT session will involve four four-minute high-intensity intervals with an intensity of at 80-95% of the HRmax interspersed with two-minute active recovery intervals with intensity of 40% to 60% of the HRmax. The resistance training session will be composed of eight exercises perform 3 sets of 8-12 repetitions with an intensity of 80% of the subject's estimated 1-RM. The HIIT only group perform 12 weeks of HIIT only. The control group subjects will be instructed not to change their usual daily physical activities routine and instructed to abstain from practicing any exercise regimens during the 12-week study period. Body composition measures, blood pressure and VO2peak will be assessed at baseline and at the end of the study period.
Results: All the outcome variables will be assessed at baseline and 12 weeks following the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Behavioral: ExerciseCombined exercise group subjects will undergo weekly three sessions of both HIIT and resistance training for sixteen weeks. The HIIT session will involve four four-minute high-intensity intervals with an intensity of at 80-95% of the HRmax interspersed with two-minute active recovery intervals with intensity of 40% to 60% of the HRmax. The resistance training session will be composed of eight exercises perform 3 sets of 8-12 repetitions with an intensity of 80% of the subject's estimated 1-RM. The HIIT only group perform 12 weeks of HIIT only. |
| control group | Other | Other: routine physical activityThe control group subjects will be instructed not to change their usual daily physical activities routine and instructed to abstain from practicing any exercise regimens during the 12-week study period. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- men aged between 40 and 60 years old,
- have been diagnosed with clinical stage 1 or 2 hypertension,
- being obese with body mass index more than 30 kg/m2
- physically inactive
Key exclusion criteria (3 listed)
- musculoskeletal problems that may limit their ability to participate in resistance or HIIT programs
- diabetes mellitus
- a history of respiratory or chronic heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseCombined exercise group subjects will undergo weekly three sessions of both HIIT and resistance training for sixteen weeks. The HIIT session will involve four four-minute high-intensity intervals with an intensity of at 80-95% of the HRmax interspersed with two-minute active recovery intervals with intensity of 40% to 60% of the HRmax. | Behavioural | study group |
| routine physical activityThe control group subjects will be instructed not to change their usual daily physical activities routine and instructed to abstain from practicing any exercise regimens during the 12-week study period. | Other | control group |
Primary outcome
blood pressure in mmhg
Time frame: 12 weeks
peak oxygen consumption in ml/kg/min
Time frame: 12 weeks
body weight in Kg
Time frame: 12 weeks
body mass index in kg/m2
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and routine physical activity in people with Hypertension, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed S Ahmed, PhD (000966564347031 ext. 00966115886326, a.aseil@psau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure in mmhg (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.